Methods and devices for fallopian tube diagnostics

ABSTRACT

Methods and devices for performing minimally invasive procedures useful for Fallopian tube diagnostics are disclosed. In at least one embodiment, the proximal os of the Fallopian tube is accessed via an intrauterine approach; an introducer catheter is advanced to cannulate and form a fluid tight seal with the proximal os of the Fallopian tube; a second catheter inside the introducer catheter is provided to track the length of the Fallopian tube and out into the abdominal cavity; a balloon at the end of the second catheter is inflated and the second catheter is retracted until the balloon seals the distal os of the Fallopian tube; irrigation is performed substantially over the length of the Fallopian tube; and the irrigation fluid is recovered for cytology or cell analysis.

RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.16/834,507, filed Mar. 30, 2020, which is a continuation of U.S.application Ser. No. 14/764,710, filed Jul. 30, 2015, which is a 371U.S. National Stage of PCT Application No. PCT/US14/14472, filed Feb. 3,2014, which claims the benefit of priority under 35 U.S.C. § 119 to U.S.Provisional Application Ser. No. 61/873,753 filed Sep. 4, 2013, and U.S.Provisional Application Ser. No. 61/759,783 filed Feb. 1, 2013, thedisclosures of which are herein incorporated herein by reference intheir entirety.

FIELD OF THE INVENTION

The present invention in general relates to Fallopian tube diagnosticsand in particular to a catheter that accommodates the anatomicaldifficulties associated with navigation within the Fallopian tube.

BACKGROUND OF THE INVENTION

Ovarian cancer is a significant disease in women; 1 out of 72 women inthe U.S. is diagnosed with ovarian cancer sometime during her lifetime.In 2012, 22,280 women in the U.S. were diagnosed with this illness, and15,500 women died of this malignancy.

Definitive detection of ovarian cancer presently requires a surgicalprocedure to obtain cell samples for diagnosis. Since the ovaries areintra-abdominal, laparoscopic or open surgery (laparotomy) must beperformed to access the ovaries for evaluation. Furthermore, biopsy ofthe ovary is not generally recommended by medical guidelines as thereexists a risk of spreading the cancer further.

Anatomically, the ovaries are in close proximity of the fimbria at theregion of the distal opening or os of the Fallopian tube. Eggs releasedby the ovary are gathered by the fimbria and transported through theFallopian tube to the uterus. In ovarian cancer, cells may be depositedin the Fallopian tube; a few of these cells may find their way into theuterus. Cell samples obtained from the uterus may detect ovarianmalignancy; however, the incidence of retrograde migration of ovariancancer cells into the uterus is too low to render uterine sampling areliable diagnostic test for ovarian malignancy. A higher number ofovarian cancer cells migrate to the Fallopian tube; this numberincreases in the distal portion of the tube, near the distal os. Theability to test cells in the Fallopian tube for malignancy would be ofconsiderable clinical value for the early detection and treatment ofsuch cancers, if such could be performed without concern about spreadingcancerous cells.

Thus, there exists a need for a device and process to allow cell samplesto be obtained from Fallopian tube for evaluation of ovarian cancer in aminimally invasively fashion and, particularly without the need for askin incision. There further exists a need for securing a sample ofrepresentative cells from the Fallopian tube with a catheter to screenfor early stage cancers

SUMMARY OF THE INVENTION

Methods and devices for performing minimally invasive procedures usefulfor Fallopian tube diagnostics are disclosed. In at least oneembodiment, the proximal os of the Fallopian tube is accessed via anintrauterine approach; an introducer catheter is advanced to cannulateand form a fluid tight seal with the proximal os of the Fallopian tube;a second catheter inside the introducer catheter is provided to trackthe length of the Fallopian tube and out into the abdominal cavity; aballoon at the end of the second catheter is inflated and the secondcatheter is retracted until the balloon seals the distal os of theFallopian tube; irrigation is performed substantially over the length ofthe Fallopian tube; and the irrigation fluid is recovered for cytologyor cell analysis.

BRIEF DESCRIPTION OF THE DRAWINGS

The present invention is further detailed with respect to the followingnon-limiting specific embodiments of the present invention. The appendedclaims should not be construed as being limited to the specific devicesso detailed.

FIGS. 1A-1D are schematic, cross-sectional side views that depict thesequential insertion of a specific embodiment of an invention catheterinto a Fallopian tube insertion catheter to seal against a Fallopiantube end (A); an everting sleeve catheter is inserted through insertioncatheter into the tube (B); a distal balloon is inflated as the sleeveis extended (C); and (D) irrigation is deployed to remove cells from theFallopian tube lumen wall;

FIG. 2 is a schematic of a hysteroscope suitable for deploying thecatheters of FIGS. 1A-1D;

FIG. 3 is a schematic view of an embodiment of a proximal introducercatheter;

FIGS. 4A and 4B are schematic, cross-sectional views of an evertingsleeve with a distal elastic balloon tip in a deflated state (A); and aninflated state (B);

FIGS. 5A and 5B are schematic, cross-sectional views of an evertingballoon with an outer construction sleeve in a deflated state (A); andan inflated state (B);

FIG. 5C is a series of photographs of an embodiment of the evertingballoon with an outer construction sleeve;

FIGS. 6A and 6B are schematic, cross-sectional views of an everting(sleeve and elastic balloon) with an inelastic delivery balloon in adeflated state (A); and an inflated state (B);

FIG. 6C is a series of photographs of an embodiment of the everting(sleeve and elastic balloon) with an inelastic delivery balloon;

FIGS. 7A and 7B are schematic, cross-sectional views of an everting(sleeve and elastic balloon) with an irrigation lumen in a deflatedstate (A); and an inflated state (B);

FIGS. 8A and 8B are schematic, cross-sectional views of an evertingballoon catheter adapted for placement within an insertion catheter, theeverting balloon catheter having a distal filament spiral, where distalis measured relative to the insertion point in a deflated state (A); andan inflated state (B);

FIG. 8C is a photograph of an exemplary spiral filament with a diameterof 15 millimeters (MM);

FIGS. 8D and 8E are schematic, cross-sectional views of an evertingballoon catheter adapted for placement within an insertion catheter, theeverting balloon catheter having a distal filament spiral heated sealedto the balloon, where distal is measured relative to the insertion pointin a deflated state (D); and an inflated state (E);

FIG. 9 is a side view of a hysteroscope for deploying the catheters ofFIGS. 8A-8E;

FIGS. 10A and 10B are schematic, cross-sectional views of an evertingballoon catheter adapted for placement within an insertion catheter, theeverting balloon catheter having a distal expanding brush, where distalis measured relative to the insertion point in a deflated state (A); andan inflated state (B);

FIGS. 11A and 11B are schematic, cross-sectional views of an evertingballoon catheter adapted for placement within an insertion catheter, theeverting balloon catheter having a distal expanding foam, where distalis measured relative to the insertion point in a deflated state (A); andan inflated state (B);

FIGS. 12A and 12B are schematic, cross-sectional views of an evertingballoon catheter adapted for placement within an insertion catheter, theeverting balloon catheter having a distal expanding inflated sphericalballoon appendage, where distal is measured relative to the insertionpoint in a deflated state (A); and an inflated state (B);

FIGS. 13A and 13B are schematic, cross-sectional views of an evertingballoon catheter adapted for placement within an insertion catheter, theeverting balloon catheter having a distal superelastic coil, wheredistal is measured relative to the insertion point in a deflated state(A); and an inflated state (B);

FIGS. 14A and 14B are schematic, cross-sectional views of an evertingballoon spiral cannula adapted for placement within an insertioncatheter, the cannula having a distal expanding inflated spiral balloonappendage, where distal is measured relative to the insertion point in adeflated state (A); and an inflated state (B);

FIGS. 15A and 15B are schematic, cross-sectional views of an evertingdistal arc balloon cannula adapted for placement within an insertioncatheter, where distal is measured relative to the insertion point in adeflated state (A); and an inflated state (B);

FIGS. 16A and 16B are schematic, cross-sectional views of an evertingballoon catheter adapted for placement within an insertion catheter, theeverting balloon catheter having a inner lumen that is pressuring toevert, where distal is measured relative to the insertion point in adeflated state (A); and an inflated state (B);

FIG. 17 is a photograph of a platinum coil wire having fibers extendingtherefrom and operative herein in the context of a catheter as depictedin FIGS. 8A-8E;

FIG. 18 is an illustration of a separate extending portion with thelumen of the catheter of FIG. 9 ; and

FIG. 19 is an illustration of the separate extending portion in deployedform beyond the orifice in the catheter of FIG. 9 .

DESCRIPTION OF THE INVENTION

The present invention has utility in engaging the interior wall of theFallopian tube and effectively removing cells therefrom for diagnosticpurposes. A device and process is provided for collecting such cells ina minimally invasive procedure that in some embodiments occurs withoutcutaneous incision.

Where a range of values is provided, it is understood that eachintervening value, to the tenth of the unit of the lower limit unlessthe context clearly dictates otherwise, between the upper and lowerlimits of that range is also specifically disclosed. Each smaller rangebetween any stated value or intervening value in a stated range and anyother stated or intervening value in that stated range is encompassedwithin the invention. The upper and lower limits of these smaller rangesmay independently be included or excluded in the range, and each rangewhere either, neither or both limits are included in the smaller rangesis also encompassed within the invention, subject to any specificallyexcluded limit in the stated range. Where the stated range includes oneor both of the limits, ranges excluding either or both of those includedlimits are also included in the invention

It must be noted that as used herein and in the appended claims, thesingular forms “a”, “an”, and “the” include plural referents unless thecontext clearly dictates otherwise. Thus, for example, reference to “aballoon” includes a plurality of such balloons and reference to “thechannel” includes reference to one or more channels and equivalentsthereof known to those skilled in the art, and so forth.

Embodiments of an inventive catheter for Fallopian tube diagnostics areprovided for the performance of minimally invasive procedures including(1) Access to the proximal os of the Fallopian tube via an intrauterineapproach; (2) Advance of an introducer catheter to cannulate and form afluid tight seal with the proximal os; (3) Use of a second catheterinside the introducer catheter to track the length of the Fallopian tubeand out into the abdominal cavity; (4) Inflation of a balloon at the endof the second catheter with retraction of the second catheter until theballoon seals the distal os of the Fallopian tube. Retraction of thesecond catheter produces contact with the intraluminal surface of theFallopian tube to dislodge cells for improved sampling; and (5) andprovisions to irrigate the Fallopian tube and recover the irrigationfluid for cytology or cell analysis.

Typically, it is very difficult to pass a catheter through the Fallopiantube. The Fallopian tube is curved, and the soft tissue of the tubecollapses, resulting in multiple constrictions as passage is attempted.In at least one embodiment of the present invention, an elongatedballoon that is initially inverted into a catheter lumen is deployed.The balloon everts upon pressurization inside the catheter, and theunrolling mechanism of the eversion creates a path through the Fallopiantube, regardless of tortuosity or constriction in the Fallopian tube.The great majority of the length of the balloon should be substantiallyinelastic, such that the balloon does not substantially expand anddilate the Fallopian tube as it everts, preferably so the Fallopian tubedoes not expand or dilate as the balloon everts. Balloon expansion mayburst or injure the Fallopian tube. However, the design alsoincorporates an elastic distal balloon end that expands to allow sealingof the distal os upon balloon retraction.

An inventive process common to the various embodiments of inventivedevices includes the deployment of the distal end of a catheter. In someinventive embodiments, an inventive catheter distal end is delivered toa proximal end of the Fallopian tube with resort to a conventionalhysteroscope. Regardless of the mode of deployment, a retracted portionof an inventive catheter is extended into contact with the interior wallof the Fallopian tube. It has been surprisingly found that the act ofextending the portion abrades sufficient cells from the Fallopian tubewall to perform histological evaluation. This is observed for planarsurfaces of seemingly non-abrasive character. While an abrasive ispresent on the tube contacting surfaces in some embodiments, such anabrasive is found not to be necessary. It has also been surprisinglyfound that withdrawal of the extended portion removes still more cells.In other inventive processes the extended portion is retracted prior tocatheter removal so as to preclude dispersal of dislodged Fallopian tubecells to surrounding tissue. Upon catheter removal contacting theexposed portion, now covered in cells with a microscope slide or otherdiagnostic substrate, is sufficient to test for abnormal cells and inparticular cancerous cells.

Referring now to the figures, in FIGS. 1A-1D an introduction catheter 10with an inverted inelastic sleeve 12 and an attached distal elasticballoon 14 is (A) inserted through an introduction catheter 10 thatresides in the working channel 22 of an operative hysteroscope 20 (FIG.2 ), and used to cannulate the proximal os of the Fallopian tube 16; (B)inflated to evert the sleeve 12 the length of the Fallopian tube 16 anddistend the distal elastic balloon 14; and (C) retracted slightly toseal the distal os 18 of the Fallopian tube 16 with the inflation of theelastic balloon 14 upon full advancement of the inverted elastic sleeve12. FIG. 1D illustrates the introduction of saline to irrigate thelength of the Fallopian tube 16 between the introducer catheter 10 andthe everted sleeve 12 with the retraction of the inflated elasticballoon 14 that seals the opening of the distal os, and the subsequentcollection of the irrigation fluid to obtain cell samples fromsubstantially the entire length of the Fallopian tube for cell analysisin the detection of ovarian cancer or other medical condition in FIG.1D.

The catheter 10 described above, and in greater detail below may beintroduced into the uterus of a patient using an operating hysteroscope20, an example of which is shown in FIG. 2 . An operating hysteroscopecontains an endoscope and multiple channels; one channel may provideirrigation to distend the uterus and allow endoscopic visualization, andone or more additional channels 22 may allow instruments and/orcatheters to be advanced distal to the hysteroscope. A ProximalIntroducer Catheter 10 (see FIG. 1A and FIG. 3 ) may be advanced throughthe working channel of the operating hysteroscope, and used to cannulatethe proximal os of a Fallopian tube. The balloon 14 on the proximalintroducer catheter 10 is inflated to occlude the proximal os, and theeverting balloon catheter is advanced through the proximal introducercatheter 10 into the proximal portion of the Fallopian tube. Thesleeve/balloon element 14 is fully everted, and the inflated balloon tippulled back to seal the distal os. Irrigation may be introduced via aport 11, and aspirated via the irrigation port 11 on the proximalintroducer catheter 10, to collect the sample. Irrigation may also beintroduced through both the everting balloon catheter and the proximalintroducer catheter, followed by aspiration through one or both ports(11, 13).

In inventive embodiments of the catheter, the sleeve 12 of the evertingsleeve catheter is preferably a flexible, elongated, substantiallyinelastic tube with an elastic balloon tip 14 attached to its distalend, see FIGS. 4A and 4B. The inelastic tube 12 may have multiple ridges15 along its length that extend externally of the tube when the tube hasbeen extended/deployed, such as illustrated in FIG. 3B. Prior todeployment, the ridges extend inwardly, as the tube is inverted, asillustrated in FIG. 3A. With the ridges extending externally, as in FIG.3B, the ridges are exposed to the luminal surface of the Fallopian tubewhen the sleeve is fully everted. These ridges increase the ability ofthe sleeve to gather cells upon balloon retraction. Alternatively, theouter surface of the everted inelastic tube may be covered with fabricor otherwise textured, to increase cell dislodgment during balloonretraction.

FIGS. 5A-5C illustrate an embodiment of an everting sleeve catheter 10Awhich provides greater protection of the bond between the balloon andthe sleeve of the everting sleeve catheter 10A during deployment,relative to that provided in the embodiment of FIGS. 4A and 4B. Theconstruction of the embodiment of FIGS. 5A-5C involves attachment of anelongated, elastic balloon to the distal tip of the everting sleevecatheter. A substantially inelastic sleeve 17, slightly shorter inlength than the elastic balloon 14, is attached to the elastic balloon14 at the distal tip of the catheter, and inverted so that it liesinside the elastic balloon. Upon eversion of the balloon/sleevecombination 14A, the inelastic sleeve emerges from a double wall 19 ofthe catheter 10A, and lies on the outside of the elastic balloon andconstricts the elastic balloon along the majority of its length, toprevent the elastic balloon from expanding and potentially rupturing theFallopian tube during the time that the everting sleeve is beingadvanced through the Fallopian tube. Upon full balloon/sleeve eversion,the distal elastic balloon inflates to 3×-5× the diameter of the sleeve,for occlusion of the distal os upon retraction of the catheter withconcomitant pullback of the inflated balloon. The catheter may contain aport 11 to allow irrigation to occur between the balloon and the outersleeve, if desired.

FIGS. 6A-6C illustrate an embodiment of an everting sleeve catheter 10Bwhere a concentric double walled catheter is provided, and the eversionof three layers are attached to the distal catheter tip: (1) anelongated inelastic balloon 21 is attached to the distal tip of theinner catheter 23, and the balloon lies within the inner catheter lumen25; (2) an elongated elastic balloon 14B equal in length to theinelastic balloon 21 is attached to the distal tip of the outer wall 27catheter 10B, and it resides inside the inelastic balloon 21; and (3) aninelastic sleeve 29 shorter in length than the elastic balloon 14B isattached to the distal tip of the outer catheter wall 27, and it liesinside the elastic balloon 14B. Pressurization of the inner catheter 23everts the inelastic balloon 21, which delivers the elastic balloon 14Band outer constricting sleeve 29. Following full eversion of all threelayers, pressurization between the walls of the inner catheter and outercatheter inflates the elastic balloon. The inelastic sleeve 29constricts the elastic balloon 14B along the majority of its length, andthe distal, un-constricted tip of the balloon 14T expands to form theocclusion element. The potential advantage of this design is a decreasein frictional characteristics during the eversion process. In thisembodiment, the inelastic balloon 21 delivers the elastic balloon andconstricting sleeve. The elastic balloon does not undergo expansionuntil it has been fully everted, and therefore does not increasefriction with the wall of an everting sleeve during eversion, as inprevious embodiments, which can be a significant advantage infacilitating deployment, particularly when working with small diametercatheters required for traversing the Fallopian tube.

FIGS. 7A and 7B illustrate an embodiment of an everting sleeve catheter10C with an inelastic sheath 29A that has a small lumen 31 forirrigation, with the lumen 29A connected to a third port 11A used forfluid irrigation and aspiration to obtain cytology samples.

A modified design is shown in FIGS. 8A-8E. An elongated balloon 32 withan expandable member 34 attached to the distal end of the balloon 32 isinverted into the lumen 36 of a catheter 30. Upon inversion, theexpandable member 34 lies inside the elongated balloon 32. In certaininventive embodiments, the expandable portion 34 is a spiral of multipleloops 38 of filament. The filament that forms the expandable member 34is readily formed from a variety of materials illustratively includingmonofilament plastic material such as Nylon or polypropylene,fluoropolymers, or polylactic acid; metal such as stainless steeltitanium, or platinum; or a superelastic metal such as Nitinol. In someembodiments a fiducial marker is present (not shown) to facilitatesubsequent return to the situs of cell sampling. It is appreciated thatthe expanding portion may also have alternative configurations. Forexample, the expanding portion 34 may contain multiple outwardlyoriented bristles 40 of plastic or metal (FIG. 17 ); or the expandingportion 34 is present as an elongated strand of material that curls 38,spreads or fans out 42, balls up 44 to a predetermined shaped whenreleased from being constrained inside the catheter (FIGS. 10A-10B orFIGS. 13A-13B); or it may be compressed plastic foam that expands uponrelease into a wet environment (FIGS. 11A-11B). Upon pressurizing thecatheter adjacent to the distal os, the balloon 32 everts so as to urgethe inverted portion outward into the extended position and into contactwith the Fallopian tube inner wall cells. In certain inventiveembodiments, upon full balloon eversion, the extending portion 34 isdelivered out of the distal os of the Fallopian tube, into the abdominalcavity. The extending portion 34 in some embodiments has to an outerdiameter of approximately 15-20 mm.

An advantage of the extending portion 34 having multiple bristles isthat there is a lot of surface area on which cells can be collected,including areas that are not likely to be exposed to shear forces whenthe device is pulled back in. This approach can maximize cell collectionand minimize the amount of cells that are wiped off when the device ispulled through the Fallopian tube or into a sheath, as seen in FIGS.17-19 . In those embodiments in which the extending portion has greatersurface area, the cell collection typically increases per linear unit ofFallopian tube so engaged under like pressurization conditions, ascompared to a contourless extending portion.

In still other embodiments of an inventive catheter, the extendingportion, upon deployment defines: multiple filaments 42 attached to thedistal end of the balloon 32 that splay out upon balloon eversion toform a brush 42 (FIGS. 10A-10B); a plastic foam structure 46 that iscompressed inside the balloon 32 and expands on balloon 32 eversion andexposure to a fluid environment (FIGS. 11A-11B); an elastic or inelasticballoon 48 on the distal end of the inelastic sleeve balloon 32 (FIGS.12A-12B), an everting balloon with a superelastic wire coil (FIGS.13A-13B), a spiral everting balloon 50 (FIGS. 14A-14B), an evertingdistal arc balloon 52 FIGS. 15A-15B); or a long elastic filament ofplastic or metal that gathers into a three-dimensional structure uponballoon eversion, such as an inner lumen 54 (FIGS. 16A-16B), andexpanding portion 34 with multiple outwardly oriented bristles 40 (FIG.17 ). It is appreciated that any of these embodiments of an inventivecatheter extending portion are readily fitting with a fiducial markerthat can be used to navigate back to the Fallopian tube as needed. Suchmarkers are known to the art and illustratively include radio-opacitymarkers, isotopic markers, and radiofrequency markers. In still otherembodiments, a biodegradable extending portion or a permanent extendingportion are severed from the catheter. In still other embodiments, theextending portion delivers a therapeutic agent such as achemotherapeutic drug, antibiotic, anti-inflammatory, or combinationsthereof of the Fallopian tube tissue.

When the catheter is pulled into the working channel of thehysteroscope, cells are dislodged from the entire length of the innersurface of the Fallopian tube. In some embodiments, the extendingportion is inverted through reduced the gas pressure with the balloon soas to shield collected cells with the catheter tip region internal bore(FIG. 18 ).

Without intending to be bound by a particular theory, the expandingportion creates friction between the outer surface of the expandingportion and the inner lining of the Fallopian tube sufficient todislodge cells and adhere such cells to the expanding portion, even incertain instances on a contourless expanding portion. The expandedspiral at the distal end of the balloon contacts the fimbria at thedistal end of the Fallopian tube, gathering cell samples as it iswithdrawn. Since the Fallopian tube increases in inner diameter as itproceeds from its proximal to its distal end, the expanding portionensures that cell samples are obtained at the distal end of the tube(fimbrial portion of the Fallopian tube). The elongated balloon and thedistal expanding portion are in certain procedural embodiments retractedinto the working channel of the hysteroscope, to avoid loss of cellsamples as the hysteroscope is removed from the patient. An elastomerseal at the proximal end of the working channel of the hysteroscopeseals against the outer surface of the catheter. A mark on the catheterbody indicates the length of retraction necessary to ensure that theelongated balloon and distal spiral lay within the hysteroscope workingchannel. Upon removal of the hysteroscope from the patient, in someembodiments, a syringe containing saline solution is attached to theLuer fitting at the proximal end of the working channel, and the salineis used to flush cells gathered by the elongated balloon and expandingspiral into a test tube. It is appreciated that the cells decorating theextending portion are readily collected for testing by conventionaltechniques and are prepared for cytological, molecular or geneticexamination.

An alternative embodiment of that shown in FIGS. 16A-16B in which a coilis attached to the end of the inverting balloon, an inner lumen formedof the exemplary material polyethylene terephthalate (PET) is attached.The eversion process follows that of the aforementioned embodiments.This alternative embodiment also includes an inflation sideport and aproximal seal that allow the balloon to be inverted while maintaining anorifice through the inner lumen in fluid communication between thehysteroscope and the patient body tissue. Once everted, the inner lumenprovides a pathway through which a separate extending portion is passedor a surgical instrument package is passed. An example of such acollection device is the spiral shown in FIG. 18 and FIG. 19 . It isappreciated that cells can be collected from a specific portion of theFallopian tubes, for example the fimbria, and then pulled back into theinner lumen so as to avoid the potential for distal cells to be wipedoff by the inner surface of the proximal Fallopian tube as the device isremoved.

Any patents or publications mentioned in this specification are hereinincorporated by reference to the same extent as if each individualpublication was specifically and individually indicated to beincorporated by reference. The foregoing description is illustrative ofparticular embodiments of the invention, but is not meant to be alimitation upon the practice thereof.

1. A catheter comprising: a tube having a proximal end and a distal end;a balloon having a distal end secured to the distal end of the tube at aproximal end of the balloon, the balloon having a length, and theballoon being adapted to evert from an inverted position to alongitudinally extended everted position in a patent; and an expandingportion disposed at the distal end of the balloon, the expanding portionpositioned inside the balloon when the balloon is in the invertedposition and the expanding portion expanding and extending beyond adistal end of the balloon when the balloon everts from the invertedposition to the everted position.
 2. The catheter of claim 1, furthercomprising a pressurized fluid source in selective communication withthe balloon.
 3. The catheter of claim 1, wherein the expanding portionhas an outer surface configured to collect and retain cells from apatient.
 4. The catheter of claim 1, wherein the expanding portioncomprises a sponge.
 5. The catheter of claim 1, wherein the expandingportion comprises an inflatable balloon.
 6. The catheter of claim 1,wherein the expanding portion comprises an expandable filament.
 7. Thecatheter of claim 6, wherein the expandable filament is a spiralfilament.
 8. The catheter of claim 6, wherein the expandable filament isa balled filament.
 9. The catheter of claim 6, wherein the expandablefilament is bristled.
 10. The catheter of claim 6, comprising aplurality of the expandable filaments.
 11. The catheter of claim 6,wherein the expandable filament is an elastic filament that gathers intoa three-dimensional structure upon balloon eversion.
 12. The catheter ofclaim 1, wherein the expanding portion comprises a compressed plasticfoam that expands upon release into a wet environment.
 13. A diagnosticdevice, comprising: a tube having a proximal end and a distal end; and aballoon having a proximal end and a distal end, the balloon beingcoupled to the distal end of the tube at the proximal end of theballoon, the balloon being movable between a first inverted position anda second everted position in a patient; and an expandable filamentdisposed at the distal end of the balloon, wherein the expandablefilament has a constrained first configuration in the first invertedposition of the balloon and an expanded second configuration in thesecond everted position of the balloon.
 14. The device of claim 13,further comprising a pressurized fluid source in selective communicationwith the balloon.
 15. The device of claim 13, wherein the expandablefilament has an outer surface configured to collect and retain cellsfrom a patient.
 16. The device of claim 16, wherein the expandablefilament is a spiral filament.
 17. The device of claim 16, wherein theexpandable filament is a balled filament.
 18. The device of claim 16,wherein the expandable filament is bristled.
 19. The device of claim 16,comprising a plurality of expandable filaments.
 20. The device of claim16, wherein the expandable filament is an elastic filament that gathersinto a three-dimensional structure upon balloon eversion.